Atopic DermatitisPhase 2NCT04212169
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
A Phase 2 study testing MEDI3506 in people with Atopic Dermatitis, run by AstraZeneca at 38 sites in 6 countries.
Trial summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- MEDI3506
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 9 Dec 2019to 20 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years inclusive at the time of consent.
- Body mass index between 19.0 and 40.0 kg/m2 inclusive.
- Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
- Meets at minimum 1 of the criteria, as follows:
- History of inadequate response to topical medications for AD
- Subject intolerance to treatment with topical medications for AD, or
Show all 10Show fewer
- Topical medications are otherwise medically inadvisable
- AD that affects ≥ 10% of the body surface area (BSA).
- An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
- An IGA score of ≥ 3.
Who cannot join
- Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
- Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
- Known active allergic or irritant contact dermatitis.
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States13 sites
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Birmingham, Alabama, 35209
Research Site
Charlotte, North Carolina, 28277
Research Site
Jacksonville, Florida, 32256
Research Site
Memphis, Tennessee, 38119
Research Site
Miami, Florida, 33180
Research Site
Orlando, Florida, 32806
Research Site
Providence, Rhode Island, 02903
Research Site
San Antonio, Texas, 78213
Research Site
San Antonio, Texas, 78229
Research Site
Santa Monica, California, 90404
Research Site
Spartanburg, South Carolina, 29303
Research Site
Tulsa, Oklahoma, 74136
United Kingdom8 sites
Research Site
Corby, NN18 9EZ
Research Site
High Wycombe, HP11 2QW
Research Site
Kenilworth, CV8 1JD
Research Site
Northwood, HA6 2RN
Research Site
Romford, RM1 3PJ
Research Site
Shipley, BD18 3SA
Research Site
Sidcup, DA14 6LT
Research Site
Wokingham, RG40 1XS
Poland6 sites
Research Site
Bialystok, 15-453
Research Site
Kielce, 25-355
Research Site
Lodz, 90-436
Research Site
Poznan, 60-681
Research Site
Skierniewice, 96-100
Research Site
Wroclaw, 50-566
Australia4 sites
Research Site
Box Hill, 3128
Research Site
Carlton, 3053
Research Site
East Melbourne, 3002
Research Site
Fremantle, 6160
Germany4 sites
Research Site
Berlin, 10117
Research Site
Dresden, 01307
Research Site
Hamburg, 20246
Research Site
Mahlow, 15831
Spain3 sites
Research Site
Alcobendas, 28100
Research Site
Leganés, 28915
Research Site
Seville, 41003
About this study
Official title: A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Read the detailed description
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.
Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
- Conditions
- Atopic Dermatitis
- Being tested
- MEDI3506, Placebo
- Keywords
- MEDI3506, Safety, Efficacy, Atopic Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI3506Drug
multiple doses
PlaceboDrug
multiple doses
| Study group | Role | What they receive |
|---|---|---|
| MEDI3506 at dose level 1 | Experimental | Participant will receive multiple doses of MEDI3506 at dose level 1. Receives: Drug: MEDI3506 |
| MEDI3506 at dose level 2 | Experimental | Participant will receive multiple doses of MEDI3506 at dose level 2. Receives: Drug: MEDI3506 |
| MEDI3506 at dose level 3 | Experimental | Participant will receive multiple doses of MEDI3506 at dose level 3. Receives: Drug: MEDI3506 |
| Placebo | Placebo comparator | Participant will receive multiple doses of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 16 in EASI Score
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Measured: Week 16
Secondary outcomes (27)
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Measured: Week 16
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Measured: Week 16
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
Measured: Week 16
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Measured: Week 16
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Measured: Week 16
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Measured: Week 16
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
Measured: Week 16
SCORAD: Percent Change From Baseline to Week 16
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Measured: Week 16
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Measured: Week 16
Change From Baseline to Week 16 in DLQI
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Measured: Week 16
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".
Measured: Week 16
Change From Baseline to Week 16 in POEM
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Measured: Week 16
Change From Baseline to Week 16 in 5-D Itch
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Measured: Week 16
Occurrence of Adverse Events
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: up to 24 weeks
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
Systolic Blood Pressure Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
Heart Rate Taken During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
Respiratory Rate Collected During Vital Signs Assessment
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: up to 24 weeks
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: up to 24 weeks
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: up to 24 weeks
Heart Rate (Beats/Min) Recorded on ECGs
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
QT (Miliseconds) Recorded on ECGs
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline, week 16 and week 24
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Week 16 and week 24
Left Ventricular Ejection Fraction Measured by Echocardiogram
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Measured: Baseline and week 16
Serum MEDI3506 Concentration Profiles
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Measured: Week 16 and week 24
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start9 Dec 2019
- Primary completion21 Jul 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212169
- Sponsor's protocol ID
- D9182C00001
- Other IDs
- 2019-003304-12, 2019
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2019
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04212169
- Acronym / sponsor ID
- D9182C00001
- Conditions
- Atopic Dermatitis
- Keywords
- MEDI3506, Safety, Efficacy, Atopic Dermatitis, Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Detailed description
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.
Approximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
| Arm | Type | Receives |
|---|---|---|
| MEDI3506 at dose level 1 | Experimental | Drug: MEDI3506Participant will receive multiple doses of MEDI3506 at dose level 1. |
| MEDI3506 at dose level 2 | Experimental | Drug: MEDI3506Participant will receive multiple doses of MEDI3506 at dose level 2. |
| MEDI3506 at dose level 3 | Experimental | Drug: MEDI3506Participant will receive multiple doses of MEDI3506 at dose level 3. |
| Placebo | Placebo comparator | Drug: PlaceboParticipant will receive multiple doses of Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 65 years inclusive at the time of consent.
- Body mass index between 19.0 and 40.0 kg/m2 inclusive.
- Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
- Meets at minimum 1 of the criteria, as follows:
- AD that affects ≥ 10% of the body surface area (BSA).
Key exclusion criteria (4 listed)
- Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
- Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
- Known active allergic or irritant contact dermatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI3506multiple doses | Drug | MEDI3506 at dose level 1, MEDI3506 at dose level 2, MEDI3506 at dose level 3 |
| Placebomultiple doses | Drug | Placebo |
Primary outcome
Percent Change From Baseline to Week 16 in EASI Score
Time frame: Week 16
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
27 secondary outcomes
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Time frame: Week 16
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Time frame: Week 16
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Time frame: Week 16
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
Time frame: Week 16
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Time frame: Week 16
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Time frame: Week 16
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Time frame: Week 16
SCORAD: Percent Change From Baseline to Week 16
Time frame: Week 16
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Time frame: Week 16
Change From Baseline to Week 16 in DLQI
Time frame: Week 16
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Time frame: Week 16
Change From Baseline to Week 16 in POEM
Time frame: Week 16
Change From Baseline to Week 16 in 5-D Itch
Time frame: Week 16
Occurrence of Adverse Events
Time frame: up to 24 weeks
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Time frame: Baseline, week 16 and week 24
Systolic Blood Pressure Taken During Vital Signs Assessment
Time frame: Baseline, week 16 and week 24
Heart Rate Taken During Vital Signs Assessment
Time frame: Baseline, week 16 and week 24
Respiratory Rate Collected During Vital Signs Assessment
Time frame: Baseline, week 16 and week 24
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Time frame: up to 24 weeks
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Time frame: up to 24 weeks
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Time frame: up to 24 weeks
Heart Rate (Beats/Min) Recorded on ECGs
Time frame: Baseline, week 16 and week 24
QT (Miliseconds) Recorded on ECGs
Time frame: Baseline, week 16 and week 24
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Time frame: Week 16 and week 24
Left Ventricular Ejection Fraction Measured by Echocardiogram
Time frame: Baseline and week 16
Serum MEDI3506 Concentration Profiles
Time frame: Week 16 and week 24
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Time frame: up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI3506 in people with Atopic Dermatitis, run by AstraZeneca at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, United Kingdom, Poland, Australia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to Week 16 in EASI Score (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.